Coinstipation Drug recall

Hey Folks,

Don't know if anybody else was put on this crap, but just in case..--og

Sales halted for constipation drug
Fri Mar 30, 6:50 PM ET
Swiss pharmaceutical maker Novartis AG will stop selling a drug to relieve
constipation after it was linked to a higher chance of heart attack, stroke
and worsening chest pain that can become a heart attack, federal health
officials said Friday.
Novartis agreed to withdraw Zelnorm at the FDA's request, the agency said
in a public health advisory.
Zelnorm, also called tegaserod maleate, is a prescription medication
approved for short-term treatment of women with irritable bowel syndrome
with constipation and for patients younger than 65 with chronic
constipation, the FDA said.
Doctors who prescribe Zelnorm should work with their patients and
transition them to other therapies as appropriate, the FDA added.
Earlier this year, Novartis gave the FDA the results of 29 clinical studies
of Zelnorm for treatment of a variety of gastrointestinal tract conditions.
The analyses showed 13 of 11,614 patients given Zelnorm had serious and
life-threatening cardiovascular side effects, while just one of the 7,031
patients given dummy pills did, the FDA and Novartis said in separate
statements.
FDA officials described the cardiovascular side effects as "a very rare
event." Still, "we concluded the benefits of this drug no longer outweighed
the risks for patients," said Dr. John K. Jenkins, director of the FDA's
Office of New Drugs.
The FDA has told Novartis it would consider allowing a limited
reintroduction of Zelnorm "if a population of patients can be identified in
whom the benefits of the drug outweigh the risks," the agency said.
Novartis said it believes the drug provides unique benefits.
"Although we have complied with the FDA's request and are collaborating
with the agency, we continue to believe that Zelnorm provides important
benefits for appropriate patients," said Dr. Stephen Cunningham, vice
president and head of U.S. clinical development and medical affairs for
Novartis.
The FDA first approved Zelnorm in 2002. The agency did not have data
concerning how often it's prescribed in the U.S.
However, Public Citizen, a consumer advocacy group, said that there were
2.13 million prescriptions issued for Zelnorm in 2005 alone, making it one
of the top 200 drugs in the country. The organization also said that it had
warned the FDA in 2001 not to approve the drug for safety reasons.
"Once again, the FDA has approved a drug with marginal effectiveness in the
face of serious questions about its safety ? putting at risk the millions
of people who have already used it," said Dr. Sidney Wolfe, director of
Public Citizen's health research group.
Jenkins said that Novartis first informed the FDA on Feb. 22 about the data
it had accumulated. The agency asked for more information for a review. On
Wednesday, FDA asked the company to discontinue marketing the drug. The
company agreed to do so on Thursday.

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